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Today's Paper | October 03, 2024

Published 13 Dec, 2021 06:20am

Vaccine patents

THE intellectual property protection regime is often seen as the villain in an otherwise picture-perfect society where all important inventions are available to everyone equally without paying any premium. But this is not a perfect world and there is a need to create incentives. Those incentives come in the form of intellectual property rights that promise returns to inventors to compensate them for the cost of the risk incurred and the intellectual labour they have invested to come up with something useful for consumers.

The debate about accessibility to inventions arises each time there is a crisis. This debate has recently become more relevant because of the restricted access of Covid vaccines to developing countries.

Vaccine-producing pharmaceutical companies are being criticised for providing vaccines to wealthier nations because of their capacity to pay so that the companies can recover the R&D costs they incurred during the vaccine’s development. For most companies, the incentive to include themselves in the race for developing a Covid vaccine was the profit they could make especially since the exercise was expensive and did not guarantee success.

However, since the pandemic is affecting both developed and developing countries, the capacity of certain nations to pay and the need to maintain the profit-making incentive of pharmaceutical companies strengthened through patents is hampering the complete eradication of Covid.

Perhaps the bigger problem has nothing to do with patents.

From a legal standpoint, the two plausible options left to counteract Covid’s spread and the unequal distribution of vaccines are: 1) the companies can give up or waive their patents, which means that non-patent holding companies could develop and distribute vaccines on a larger scale, or 2) states that have granted patents to inventions can invoke compulsory licensing provisions under their relevant laws to temporarily limit the monopoly of pharmaceutical companies and facilitate licences for non-patent holding companies.

The former is unlikely since it would requ­i­­­re a concerted waiver or licensing by all patent holders — a collective action problem. But the latter could work albeit in a restricted way.

Under Section 58 of the Patents Ordinance, 2000 — Pakistan’s main legislation on patents — the government may decide to exploit the patent without the owner’s consent or demand the owner give away a compulsory licence. This means that if a Pakistani or foreign pharmaceutical company has a patent for its Covid vaccine in Pakistan under Section 8 of the Patents Ordinance, 2000, the government can force the owner to grant a compulsory licence to other pharmaceutical companies to mass-produce the vaccine if it contributes positively to the health sector or if the patent holder refuses to grant a licence to a third party on reasonable commercial terms. So, anyone can have their intellectual property appropriated by the government subject to (i) its being in the public interest, and (ii) compensation having been provided to the person who came up with the vaccine on fair, reasonable, and non-discriminatory terms.

While compulsory licensing is a good option since it will provide some compensation to pharmaceutical companies, it may not be effective in addressing the inequity in vaccine access. Perhaps the bigger problem has nothing to do with the patent system in the first place.

While it has been labelled as the big bad wolf, the patent system has been created to ensure that the grant of the monopoly is limited. One gatekeeper is the regional nature of the patents, which means there is no international patent and each country grants a patent on its own merits ie a patent will be only valid in a country if it is registered there, otherwise, it will be part of the public domain. In such cases, compulsory licensing would only work where the patent is registered in the first place but in all other cases, there would be no prohibition on the large-scale development of vaccines because there will be no patent.

There are other issues that need to be addressed before the patent system is held responsible for the limited accessibility of Covid vaccines. For example, while the formula of the vaccine may be part of the public domain in the absence of a regional patent, there may not be an effective transfer of knowledge or proper equipment and the funds to procure that equipment. Another issue could be geopolitical considerations such as the tussle between the US and Chinese vaccines or US and Russian vaccines, their recognition internationally etc. Further, a waiver or compulsory licensing of the patent will not solve the problem of limited raw material including human intellectual capital, production sites and storage for vaccines, especially in Pakistan.

A waiver on patents may just be the tip of the iceberg, hence, issues beyond the sphere of patents need to be addressed before they can be blamed for adding to the inequality of access to vaccines.

The writer is a lawyer.

Published in Dawn, December 13th, 2021

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